The purpose of this study is to assess the safety and efficacy of various dose levels of NG101 compared with placebo in adult participants with gastroparesis during 12 weeks of treatment.
This is a randomized, double-blind, parallel-group , placebo-controlled, multicenter US-based study to evaluate the safety and efficacy of 3 dose levels of NG101 (Metopimazine mesylate) compared with placebo in participants with diabetic or idiopathic gastroparesis. The study will enroll approximately 140 participants. Following the Screening Period, there is a 2-week Pretreatment Period during which participants will complete an electronic daily diary. Participants eligible for the clinical study will be randomly assigned (in a 1:1:1:1 ratio) to receive either NG101 5 mg, 10 mg, or 20 mg, or matching placebo during a 12-week Treatment Period. All participants will be asked to take one capsule 30 minutes before a meal 3 times a day and 30 minutes before bedtime for a total of 4 capsules daily (QID). The total duration of the study for each participant will be approximately 20 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
161
Change From Baseline of Nausea Severity Score
Change from Baseline at Weeks 7 through 12 (average) as measured by the Diabetic and Idiopathic Gastroparesis Symptoms Daily Diary (DIGS-DD). Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week in the 2-week Pretreatment Period, the 12-week Treatment Period, and the 2-week Follow-up Period, a participant's score for that week was the mean of the daily scores for that week. A negative change from baseline indicates improvement.
Time frame: Baseline to Week 12
Change From Baseline in Early Satiety Severity Score
Change from baseline at Weeks 7 through 12 (average) as measured by the Diabetic and Idiopathic Gastroparesis Symptoms Daily Diary (DIGS-DD) for early satiety severity score. Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week in the 2-week Pretreatment Period, the 12-week Treatment Period, and the 2-week Follow-up Period, a participant's score for that week was the mean of the daily scores for that week. A negative change from baseline indicates improvement.
Time frame: Baseline to Week 12
Change From Baseline in Postprandial Fullness Severity Score
Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for postprandial fullness severity score. Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week in the 2-week Pretreatment Period, the 12-week Treatment Period, and the 2-week Follow-up Period. A negative change from baseline indicates improvement.
Time frame: Baseline to Week 12
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Digestive Health Specialists
Dothan, Alabama, United States
G & L Research, LLC
Foley, Alabama, United States
East View Medical Research
Mobile, Alabama, United States
Phoenix Medical Group
Peoria, Arizona, United States
Phoenix Clinical LLC
Phoenix, Arizona, United States
Del Sol Research Management
Tucson, Arizona, United States
Preferred Research Partners
Little Rock, Arkansas, United States
GW Research, Inc
Chula Vista, California, United States
Precision Research Institute, LLC
Chula Vista, California, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, United States
...and 73 more locations
Change From Baseline in Abdominal Pain Severity Score
Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for postprandial fullness severity score. Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week in the 2-week Pretreatment Period, the 12-week Treatment Period, and the 2-week Follow-up Period. A negative change from baseline indicates improvement.
Time frame: Baseline to Week 12
Change From Baseline in Discrete Episodes of Vomiting
Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for the number of discrete episodes of vomiting. Participants were asked to record the number of episodes of vomiting in the past 24 hours. Each episode counts as "1". A negative change from baseline indicates improvement.
Time frame: Baseline to Week 12
Change From Baseline in 3-symptom Severity Score
Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for 3-symptom severity score. Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week, the 3-symptom severity score is the average of the mean daily scores of nausea, early satiety, and postprandial fullness severity scores. A negative change from baseline indicates improvement.
Time frame: Baseline to Week 12
Change From Baseline in 4-symptom Severity Score
Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for 4-symptom severity score. Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week, the 4-symptom severity score is the average of the mean daily scores of nausea, early satiety, postprandial fullness, and abdominal pain severity scores. A negative change from baseline indicates improvement
Time frame: Baseline to Week 12